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Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study

Primary Purpose

Chronic Kidney Diseases, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Honey Spice Group
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults who have been diagnosed with CKD and/or have a BMI >24.9
  • have no additional chronic diseases or GI disorders or GI disturbances
  • age 18 years or older
  • no food allergies or dietary restrictions
  • all with no contraindications to consuming anything by mouth as per their physician

Exclusion Criteria:

  • no diagnosis of CKD or BMI <24.9
  • GI disorders, diagnosed with other chronic diseases and conditions, gastrointestinal disturbances
  • pregnant and/or lactating
  • under 18 years old
  • food allergies to wheat, almonds, or aversion to turmeric, cinnamon, and honey. -Dietary restrictions as medically indicated
  • trouble chewing/swallowing as confirmed by physician

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Honey Spice Group

Arm Description

The dietary intervention will be a 10-day feasibility trial, using a honey, spice infused baked good. The participants will receive the baked good on day 1 and will be asked to consume a 50-gram baked good daily for 10 days with or without their meals. The honey, spice infused baked good will contain 15g honey and 3g of spice blend (turmeric and cinnamon). A saliva sample will be taken at the start of the intervention (day 1) before consumption of the baked good and after the intervention ends (day 10), 2 hours after consuming the final baked good. Additionally, participants will provide a urine sample to determine microalbuminuria level, complete a spice-consumption survey and a semi-quantitative food frequency questionnaire (day 1). At day 10, participants will indicate if their spice consumption and dietary intake has changed over the past 10 days. Each day, they will tick off the amount of baked good consumed (100%, 75%, 50%, 25%, 0%).

Outcomes

Primary Outcome Measures

inflammation markers
Difference in salivary inflammation marker, CRP, concentration pre and post.
inflammation markers
Difference in salivary inflammation marker, IL-6, concentration pre and post.

Secondary Outcome Measures

Dietary and Spice habits
Relationship between dietary and spice habits and inflammation markers

Full Information

First Posted
September 13, 2021
Last Updated
April 15, 2022
Sponsor
University of Florida
Collaborators
National Kidney Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05055362
Brief Title
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
Official Title
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florida
Collaborators
National Kidney Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to determine the effect a spiced-infused baked good has on inflammatory biomarkers in adults who are overweight and/or who has chronic kidney disease. Participants will be involved for 10 days in this research study.
Detailed Description
The dietary intervention will for 10-days, in which participants will eat a baked good each day for a total of 10 days. This baked good contains honey and spices (cinnamon and turmeric). At the first day of the study, participants will provide a urine sample, saliva sample, be weighed, take a pregnancy test, complete a total of 3 surveys - dietary and spice intake and demographics. Each survey will take no more than 10 minutes for a total of 30 minutes. At the end of the 10 days, participants will provide a saliva sample and complete 2 surveys - dietary and spice intake. Each survey will take no more than 10 minutes for a total of 20 minutes. Each day of the baked good intervention, participants will tick off the amount of baked good consumed (100%, 75%, 50%, 25%, 0%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Honey Spice Group
Arm Type
Experimental
Arm Description
The dietary intervention will be a 10-day feasibility trial, using a honey, spice infused baked good. The participants will receive the baked good on day 1 and will be asked to consume a 50-gram baked good daily for 10 days with or without their meals. The honey, spice infused baked good will contain 15g honey and 3g of spice blend (turmeric and cinnamon). A saliva sample will be taken at the start of the intervention (day 1) before consumption of the baked good and after the intervention ends (day 10), 2 hours after consuming the final baked good. Additionally, participants will provide a urine sample to determine microalbuminuria level, complete a spice-consumption survey and a semi-quantitative food frequency questionnaire (day 1). At day 10, participants will indicate if their spice consumption and dietary intake has changed over the past 10 days. Each day, they will tick off the amount of baked good consumed (100%, 75%, 50%, 25%, 0%).
Intervention Type
Other
Intervention Name(s)
Honey Spice Group
Intervention Description
Consume baked good daily for 10 days and provide samples of saliva, urine and dietary habits and spice intake.
Primary Outcome Measure Information:
Title
inflammation markers
Description
Difference in salivary inflammation marker, CRP, concentration pre and post.
Time Frame
10 days
Title
inflammation markers
Description
Difference in salivary inflammation marker, IL-6, concentration pre and post.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Dietary and Spice habits
Description
Relationship between dietary and spice habits and inflammation markers
Time Frame
10 days
Other Pre-specified Outcome Measures:
Title
Albuminuria
Description
Determining relationship between inflammation markers and albuminuria
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults who have been diagnosed with CKD and/or have a BMI >24.9 have no additional chronic diseases or GI disorders or GI disturbances age 18 years or older no food allergies or dietary restrictions all with no contraindications to consuming anything by mouth as per their physician Exclusion Criteria: no diagnosis of CKD or BMI <24.9 GI disorders, diagnosed with other chronic diseases and conditions, gastrointestinal disturbances pregnant and/or lactating under 18 years old food allergies to wheat, almonds, or aversion to turmeric, cinnamon, and honey. -Dietary restrictions as medically indicated trouble chewing/swallowing as confirmed by physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette Andrade
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will only be able to provide group information such as demographics

Learn more about this trial

Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study

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